Lactate Gen.2 3183700190

GUDID 04015630918911

Roche Diagnostics GmbH

Lactate IVD, kit, enzyme spectrophotometry

• Primary Device ID: 04015630918911
• NIH Device Record Key: 1033d2f4-7127-4c4f-8df1-b4fc31fe9311
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lactate Gen.2
• Version Model Number: 3183700190
• Catalog Number: 3183700190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630918911 [Primary]

FDA Product Code

• KHP: ACID, LACTIC, ENZYMATIC METHOD

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-26
• Device Publish Date: 2021-01-18

On-Brand Devices [Lactate Gen.2]

• 07613336121351: 08057940190
• 04015630926954: 5401666190
• 04015630925148: 5171881190
• 04015630918911: 3183700190